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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Vacuum, Radio Frequency Induced Heat
510(k) Number K151296
Device Name Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250)
Applicant
BIOS S.R.L.
VIA GUIDO ROSSA, 10/12
VIMODRONE,  IT I-20090
Applicant Contact RICCARDO PISATI
Correspondent
BIOS S.R.L.
VIA GUIDO ROSSA, 10/12
VIMODRONE,  IT I-20090
Correspondent Contact RICCARDO PISATI
Regulation Number878.4400
Classification Product Code
PBX  
Date Received05/15/2015
Decision Date 11/19/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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